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Product Catalogue: Gke Gke

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0% found this document useful (0 votes)
46 views28 pages

Product Catalogue: Gke Gke

Uploaded by

Sunila Akram
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 28

Product Catalogue

gke Steri-Record® and gke Clean-Record®


Process challenge devices,
chemical indicators and accessories
for cleaning and sterilization processes

Bowie-Dick-Simulation Test
Batch- and Process Monitoring Systems
Documentation System
steam, ethylene oxide, formaldehyde
and hydrogen peroxide sterilization processes

Cleaning processes

710-002 EN V22 06/2013 Page 1 of 28


710-002 EN V22 06/2013 Page 2 of 28
Content

Bowie-Dick-Simulation Test ............................................................................................. 5


Process and Batch Monitoring System (PMS + BMS) .................................................... 6
Hollow load test for small and large sterilizers ................................................................ 6
High demand hollow PMS ............................................................................................... 6
Load related BMS ........................................................................................................... 7
Chemical indicator strips for PMS and BMS (steam) ....................................................... 7
Package Monitoring Indicators for steam sterilization processes ................................ 8
Class 4 indicators............................................................................................................ 8
Class 5 indicators............................................................................................................ 8
Class 6 indicators............................................................................................................ 9
Process indicators for steam sterilization processes .................................................. 10
Double self-adhesive labels for printers with cutting device .......................................... 10
Double self-adhesive labels for printers with split .......................................................... 11
Container label .............................................................................................................. 13
Container seal............................................................................................................... 13
Autoclave tape .............................................................................................................. 13
Indicators for ethylene oxide sterilization processes ................................................... 14
Indicators for formaldehyde sterilization processes .................................................... 16
Indicators for hydrogen peroxide sterilization processes ........................................... 17
Testsets and process challenge devices (PCDs) .......................................................... 19
Documentation System ................................................................................................... 21
Single self-adhesive 3-line labels .................................................................................. 21
Double self-adhesive 3-line labels ................................................................................. 22
3-line eco documentation labels .................................................................................... 23
Combination of different labels...................................................................................... 23
Cleaning Indicators and Process Challenge Devices (PCDs) .................................. 24
Cleaning indicators for WDs ......................................................................................... 24
PCDs and cleaning indicator holder .............................................................................. 25
Cleaning indicators for ultrasonic cleaning baths .......................................................... 26

710-002 EN V22 06/2013 Page 3 of 28


710-002 EN V22 06/2013 Page 4 of 28
1. Chemical indicators to monitor steam sterilization processes
1.1 Bowie-Dick-Simulation Test
used in vacuum steam sterilization processes checking leaks, non condensable gases (NCG) and/or insuffi-
cient air removal and therefore sufficient steam penetration. The BDS indicator strip is placed into the BDS-
test device and sterilized in an empty chamber at 121°C, 15 min or 134°C, 3.5 min (BD-test program). Please
refer to the gke-colour reference chart for interpretation.

1.1.1 Process challenge devices


STEAM PENETRATION AIR REMOVAL

European Versions American Version


EU-Version EU-Version USA-Version
Simulating 7 kg cotton pack according to Simulationg 7 kg cotton pack Simulating 4 kg cotton pack
EN ISO 11140-4 and hollow load test according to EN ISO 11140-4 according to ISO 11140-5
according to EN 867-5

Art-No. 211-151 Compact-PCD® (blue) Art-No. 211-121 Compact-PCD® (purple) Art-No. 211-131 Compact-PCD® (light blue)
Art-No. 211-150 Start-up kit, consisting of a Art-No. 211-120 Start-up kit, consisting of a Art-No. 211-130 Start-up kit, consisting of a
Compact-PCD® (blue) and Compact-PCD® (purple) and Compact-PCD® (light blue) and
100 BDS-indicator strips 100 BDS-indicator strips 100 BDS-indicator strips

1.1.2 BDS-indicator strips


are equal for all versions and are included in all BDS start-up kits and refill packs.

before sterilization after successful sterilization

Refill packs
Art.-No. Product code Quantity
211-111 100
211-112 C-S-BDS-SV1 250
211-115 500

710-002 EN V22 06/2013 Page 5 of 28


1.2 Batch and Process Monitoring Systems STEAM
Batch Monitoring Systems (BMS) are validated according to the load configuration and are used for rou-
tine monitoring of each batch. Process Monitoring Systems (PMS) are described as process challenge
devices (PCD) in the standard and are used to check sterilizers, so-called type tests. They proof if a steri-
lizer fulfils the standard specification (e.g. BD-Test and Hollow Load Test according to EN 285 and
EN 867-5). A PMS can also be used as a BMS, if the penetration performance of the sterilizer exceeds the
penetration performance of the load to be sterilized.

The indicator strip is placed into the PCD. The test device is sterilized together with the load. Please refer
to the gke-colour charts for interpretation. More PCDs and testsets can be found in section 5.

1.2.1 Process challenge devices (Hollow load test)

Art.-No. Content Art.-No. Content


Start-up kit, consisting of 1 Compact- Start-up kit, consisting of 1 Compact-PCD,
211-253 211-254
PCD, round and 100 indicator strips oval and 100 indicator strips
200-020 1 Compact-PCD, colour: gren, round 200-024 1 Compact-PCD, colour: green, oval

1.2.2 Process challenge devices (Hollow load test according to EN 867-5)

Art.-No. Content Art.-No. Content


Start-up kit, consisting of 1 Compact- Start-up kit, consisting of 1 Compact-PCD,
211-263 211-264
PCD, round and 100 indicator strips oval and 100 indicator strips
200-021 1 Compact-PCD, colour: orange, round 200-026 1 Compact-PCD, colour: orange, oval

1.2.3 High-Demand-Hollow Process Monitoring System (HDH-PMS)

Art.-No. Content
200-029 1 Compact-PCD, colour: red, round

710-002 EN V22 06/2013 Page 6 of 28


1.2.4 Load validated process challenge devices STEAM

Art.-No. Content Art.-No. Content Art.-No. Content


Start-up kit, consisting of Start-up kit, consisting of Start-up kit, consisting of
1 Compact-PCD, white 1 Compact-PCD, yellow 1 Compact-PCD, black
211-291 211-281 211-271
(Ophthal-BMS) and (Dental-BMS) and (Tattoo-BMS) and
100 indicator strips 100 indicator strips 100 indicator strips
200-091 1 Compact-PCD, colour: white 200-081 1 Compact-PCD, colour: yellow 200-071 1 Compact-PCD, colour: black

1.2.5 BMS- and PMS-indicator strips for standard steam sterilization processes to be used in
all gke-tests, Stated Value (SV) = 121°C, 15 min or 134°C, 3 min. and are
induded in all start-up kits and refill packs.

before sterilization after successful sterilization

Refill packs
Art.-No. Product code Quantity
211-252 250
C-S-PM-SV1
211-255 500

1.2.6 BMS- and PMS-indicator strips for prion steam sterilization processes to be used in
all gke-tets, Stated Value (SV) = 134°C, 18 min

before sterilization after successful sterilization

Refill packs
Art.-No. Product code Quantity
211-211 100
211-212 C-S-PM-SV2 250
211-215 500

710-002 EN V22 06/2013 Page 7 of 28


STEAM
1.3 Package monitoring indicators for steam sterilization processes
Package monitoring indicators are used inside packs to monitor all relevant parameters of steam sterilization
processes. This type of indicators should only be used if solid and porous goods are sterilized. Package moni-
toring indicators only provide sterility information at the position inside the chamber where they are located.
The application inside of packs is absolutely necessary, if sterilization processes without forced air removal
are used and a BDS-Test or a Process Monitoring System cannot be used. All steam indicators fulfil the re-
quirements of class 4, 5 or 6 indicators according to the European Standard EN ISO 11140-1.

1.3.1 Class 4 package monitoring indicators for steam sterilization processes

before sterilization After successful sterilization

Art.-No.: 211-403, C-S-P-4-SV1


(available as package with 3.200 labels on indicator cards)

Other language version can be produced if a minimum volume of 1.000.000 labels is ordered.
Currently available in English and Chinese (Art.-No.: 211-413 “Chemo-D-P-4” Chinese Version)

1.3.2 Class 5 package monitoring indicators for steam sterilization processes

Label
dimension:
14 x 65 mm

before sterilization after successful sterilization

Art.-No. Product code Quantity


211-224 400
211-225 C-S-P-5-SV1 800
211-226 3.200

Currently available in English and Chinese (Art.-No.: 211-228 Chinese Version)

710-002 EN V22 06/2013 Page 8 of 28


Art.-No. Product Code Quantity Art.-No. Product Code Quantity
211-230 C-S-P-5-78x48-SA-SV1 1.000 211-220 C-S-P-5-58x35-SV1 1.000
211-235 Size: 48 x 78 mm 500 211-222 Size: 58 x 35 mm 200

1.3.3 Class 6 package monitoring indicators for steam sterilization processes


for standard steam sterilization processes prion steam sterilization processes
SV = 121°C, 15 min and 134°C, 3 min SV = 134°C, 18 min

Label
dimension:
23 x 66 mm

before after before after


successful sterilization successful sterilization

Art.-No. Product code Quantity


211-241 2.000
211-242 C-S-P-6-SV1 (Standard) 500
211-243 250
211-238 2.000
211-239 C-S-P-6-SV2 (Prion) 500
211-240 250

710-002 EN V22 06/2013 Page 9 of 28


1.4 Process indicators for steam sterilization processes STEAM

Usage and colour change


process indicators are adhered on each sterilization package and change their colour during the steriliza-
tion to provide the logistical information if the pack has passed the sterilization process or not. Process in-
dicators do not inform about the quality of the sterilization process.

The label can be adhered on sterilization packs or pouches and after opening them for medical treatment they
can be transferred to the patient documentation. Due to the different layout (alignment) of the splits the labels
can be separated according to their usage. This allow specific information or barcode to be documented sepa-
rately in different locations.
All gke process indicators for steam sterilization change their colour from blue to brown/black as shown:

before sterilization after sterilization

1.4.1. Double-adhesive endless label for printers with cutting device

Product Code C-S-L-1-70-DA


Label Outside roll Roll
Art.-No. Label width
length diameter core
211-390 7 cm 70 m 15.7 cm 3“

710-002 EN V22 06/2013 Page 10 of 28


1.4.2. Labels for printers
The double self-adhesive labels are available on rolls with 1.5, 2 and 3” core and have a perforation between
each label and different label amounts per roll and outside diameters. Other label amounts per roll and outside
core diameters are available on request. The core diameter and outside core diameter is stated underneath
each product. Plastic inserts to reduce the core diameter to 2” or 1” are available free of charge. Colour refer-
ence see 1.4.

1.4.2.1. Label 35 x 58 mm

Split 10 mm
from bottom

Corner split

Labels/ Outside roll


Art.-No. Product code Dimensions Roll core Split
roll diameter
211-342 C-S-L-1-60x40-SC-DA 3“ Corner
12 cm
211-344 35 x 58 mm 800
C-S-L-1-60x40-SU-DA Horizontal
211-345 10.6 cm 2“

1.4.2.2. Label 35 x 78 mm

Split 10 mm
from bottom

Corner split

Labels/ Outside roll


Art.-No. Product code Dimensions Roll core Split
roll diameter
211-346 C-S-L-1-80x40-SC-DA Corner
35 x 78 mm 800 12 cm 3“
211-348 C-S-L-1-80x40-SU-DA Horizontal

1.4.2.3. Label 48 x 78 mm

Horizontal split 16 mm Product code C-S-L-1-80x50-W-SU-DA


from bottom Labels/ Outside roll Roll
Art.-No.
roll diameter core
211-373 750 12.5 cm 3“

710-002 EN V22 06/2013 Page 11 of 28


1.4.2.4. Label for Getinge documentation system 56 x 102 mm

Horizontal split Product code C-S-L-1-SL-DDOC


Labels/ Outside roll Roll
Art.-No.
roll diameter core
211-369 800 12 1.5“
Vertical split 211-375 2.000 19,4 3“

1.4.2.5. Label 38 x 39 mm

Product code C-S-L-1-38x39-SC-DA


Labels/ Outside roll Roll
Art.-No.
roll diameter core
211-377 700 10.5 2“

Split: bottom right corner

1.4.2.6. Label 58 x 72 mm

Horizontaler Split Product code C-S-L-1-58x72-SM-DA


Labels/ Outside roll
Art.-No. Roll core
roll diameter
211-378 400 2“
10
211-381 450 1.5“

710-002 EN V22 06/2013 Page 12 of 28


1.4.3. Single self-adhesive data label
The labels (48 x 78 mm) are available on roll with 3“ core (1.000 labels/roll) with perforation between each la-
bel. Colour changes see 1.4.

Art.-No.: 211-382
C-S-L-1-80x50-WF-SA

1.4.4. Self-adhesive container label


The perforated self-adhesive container labels (60 x 38 mm) are available on roll with 3“ core (1.000 labels/roll).
Before use the label can be written on manually or by printer and then put into packs, pouches or slipped on
containers which have to sterilized. After sterilization they are adhered onto the patient documentation sheet.

Art.-No.: 211-341, C-S-L-1-CL-40x60-SA

1.4.5. Container seal


The adhesive seal with a process indicator can seal containers and has space to adhere a 3-line label (see
point 5.). Colour changes see 1.4.1.

Art.-No.: 211-362, C-S-L-1-CS

1.4.6. Autoclave tape


adhesive with process indicator to seal packs, roll of 50 m lengths and 19 mm width.

before sterilization after passing through sterilization process


Art.-No.: 211-351, C-S-L-1-AT

710-002 EN V22 06/2013 Page 13 of 28


2. Chemical indicators to monitor ethylene oxide sterilization processes

2.1 Process challenge device (PCD)


EO
used in ethylene oxide sterilization processes to monitor the efficiency of EO-gas in each batch. The indi-
cator strip is placed into the PCD. The test device is sterilized together with other packages and contain-
ers.

Art.-No. Product code Quantity


1 + 200
212-250 C-E-PM-HPCD-KIT (Start-up kit, consisting
of 1 PCD and
200 indicator strips)
200-028 C-E-PM-HPCD 1 PCD

2.2 Indicator strips for ethylene oxide sterilization processes


The indicator strips can be used in the PCD above. A successful sterilization is indicated by a colour change
from blue to green.

before sterilization after successful sterilization


Refill packs
Art.-No. Product code Quantity
212-202 C-E-PM 250

2.3 Self-adhesive package monitoring indicator

Art.-No.: 212-206, C-E-P-5-58x35-W-SV3


Label dimension: 58 x 35 mm

Available as package with 200 labels (zig-zag-folded)

2.4 Class 4 package monitoring indicators for ethylene oxide sterilization processes

before sterilization after successful sterilization

Art.-No.: 212-360, C-E-P-4-SV3


(available as package with 3.200 labels on indicator cards)

710-002 EN V22 06/2013 Page 14 of 28


2.5 Label for Getinge documentation system 56 x 102 mm

Horizontal split
Product code C-E-L-1-SL-DDOC
Labels/ Outside roll Roll
Art.-No.
roll diameter core
212-374 400 11 3“

Vertical Split

710-002 EN V22 06/2013 Page 15 of 28


3. Chemical indicators to monitor formaldehyde sterilization processes
FORM
3.1 Process challenge device (PCD)
used in LTSF-sterilizers to test sufficient formaldehyde penetration. The indicator strip is placed in the test de-
vice. The test device is sterilized together with other packages and containers. Compact-PCDs can also be
used for this application, see section 5.

Introduction pack:
Art.-No.: 213-260 C-F-PM-HPCD-KIT
(consisting of a Helix-PCD according to EN 867-5
and 200 integrating indicator strips)

3.2 Indicator strips for formaldehyde sterilization processes


The indicator strips can be used in the PCD above.A successful sterilization process is indicated by a col-
our change from yellow to brown.

before sterilization after successful sterilization


Art.-No.: 213-203, C-F-PM (refill pack with 250 indicators)

3.3 Self-adhesive package monitoring indicator

Art.-No.: 213-206, C-F-P-5-58x35-W-SV4


Label dimension: 58 x 35 mm

Available as package with 200 labels (zig-zag-folded)

3.4 Double-adhesive endless labels with indicator on roll with 3” core for printers with cut-
ting device (7 cm x 70 m)
After the information is printed and the label is cut to the required length inside the printer it can be adhered
on sterilization packs or pouches and after opening them for medical treatment they can be transferred onto
the patient documentation. The chemical indicator provides the logistic information if the package has passed
the sterilization process. Outside roll diameter: 15.7 cm.

Product code C-F-L-1-70-DA


Label Label Outside roll Roll
Art.-No.
width length diameter core
213-390 7 cm 70 m 15.7 cm 3“

710-002 EN V22 06/2013 Page 16 of 28


4. Chemical indicators to monitor hydrogen peroxide (H2O2)/ VH2O2
plasma sterilization processes
No cellulose carriers (paper) should be used for hydrogen peroxide sterilization processes as cellulose
decomposes H2O2 into oxygen and water. Therefore a plastic carrier is used.
4.1 Testset and Process challenge devices (PCD)
used in hydrogen peroxide sterilization processes. The indicator strip is placed in the test device. The test de-
vice is sterilized together with other packages and containers.
Tube
Art-No. Product code Diameter Length Quantity
[mm] [cm]
200-016 PM-HPCD-TS-10 10
200-225 PM-HPCD-2-25 2 25
200-325 PM-HPCD-3-25 3 25
200-350 PM-HPCD-3-50 3 50
200-425 PM-HPCD-4-25 4 25
200-450 PM-HPCD-4-25 4 50
1
200-475 PM-HPCD-4-75 4 75
200-525 PM-HPCD-5-25 5 25
200-550 PM-HPCD-5-50 5 50
200-575 PM-HPCD-5-75 5 75
200-510 PM-HPCD-5-100 5 100

4.2 Indicator strips for hydrogen peroxide sterilization processes


The indicator strips can be used in the PCDs above. Please refer to the gke colour reference chart for inter-
pretation.

before sterilization After successful sterilization


Art.-No.: 214-203, C-V-PM (Refill pack with 250 indicators)

4.3 Self-adhesive package monitoring indicator

Art.-No.: 214-206, C-V-P-58x35-W


Label dimension: 58 x 35 mm

Available as package with 200 labels


(zig-zag-folded)

4.4 Self-adhesive package monitoring indicator, without marking possibility


gke Steri-Record® C-V-P gke Steri-Record® C-V-P

Hydrogenperoxide/Plasma Hydrogenperoxide/Plasma
VH2O2 Packing Indicator VH2O2 Packing Indicator

before sterilization After successful sterilization


Art.-No. Product Code Quantity
214-221 400
214-222 C-V-P 800
214-223 3.200

710-002 EN V22 06/2013 Page 17 of 28


4.5 Labels for printers with hydrogen peroxide process indicator double-adhesive endless
The double self-adhesive labels with class 1 process indicator according to EN ISO 11140-1 are used in print-
ers with and without cutting device. After the information is printed and the label can be adhered on steriliza-
tion packs or pouches and after opening them for medical treatment they can be transferred to the patient
documentation. The chemical indicator provides the logistic information if the package passed the hydrogen
peroxide sterilization process.

4.5.1. Endless labels to be used in printers with cutting device

Product code C-V-L-1-70-DA


Label Label Outside roll Roll
Art.-No.
width length diameter core
214-390 7 cm 60 m 14.7 cm 3“

4.5.2 Label 78 x 48 mm

Product code C-V-L-1-80x50-SU-DA


Labels/ Outside roll Roll
Art.-No.
Roll diameter core
214-373 750 12.5 cm 3“

Split 16 mm
from buttom

4.5.2 Label for Getinge documentation system 56 x 102 mm


C-V-L-1-SL-DDOC purple  pink
EN ISO 11140-1 Class 1

Horizontal split
Product code C-V-L-1-SL-DDOC
Labels/ Outside roll Roll
Art.-No.
gke

roll diameter core


214-369 800 12 cm 1.5“
VH2O2

Vertical Split

710-002 EN V22 06/2013 Page 18 of 28


5. Testsets and Process challenge devices (PCD)
STEAM
Testsets are used to check the limitations of different sterilization processes. Testsets con- EO
tain process challenge devices (PCDs) with different penetaration characteristics. All PCDs
can be used with gke biological or chemical indicators, available for steam, ethylene oxide, FORM
formaldehyde and hydrogen peroxide sterilization processes. Please order the correspond- VH2O2
ing biological or chemical indicator strips with the testset, see section 1.2.5 (steam), 2.2
(ethylene oxide), 3.2 (formaldehyde) or 4.2 (hydrogen peroxide/plasma).

5.1 Compact-PCD®-Testset, consisting of 9 Compact-PCD®s

Art.-No.: 200-210, PM-RCPCD-TS

All PCDs and testsets are also available as single devices and some of them are identical with other appli-
cations, see 1.2

Art-No. Product Code Content


Sensitivity Validated according
200-211 PM-RCPCD-1 Equivalent to gke-Tattoo-BMS (black)
Tattoo load
Art.-No. 200-071
200-212 PM-RCPCD-2 PCD with higher penetration characteris-
tics of the Tattoo-BMS and lower of the No reference
Dental-BMS (yellow)
200-213 PM-RCPCD-3 Equivalent to gke-Dental-BMS (yellow)
Dental load
Art.-No. 200-081
200-214 PM-RCPCD-4 PCD with higher
No reference
200-215 PM-RCPCD-5 penetration characteristics
200-216 PM-RCPCD-6 Equivalent to gke-Ophthal-BMS (white)
Ophthalmology load
Art.-No. 200-091
200-217 PM-RCPCD-7 Equivalent to gke-BMS 7 kg BD cotton pack EN 285
(green) Art.-No. 200-020 with biological indicators
200-218 PM-RCPCD-8 Equivalent to gke-BMS
Hollow load test according to EN 867-5
(orange) Art.-No. 200-021
200-219 PM-RCPCD-9 More demanding penetration
Equivalent to gke-BMS
characteristics than hollow load test
(red) Art.-No. 200-029 according to EN 867-5

710-002 EN V22 06/2013 Page 19 of 28


5.2 Helix-PCD-Testsets

5.2.1 Testset, consisting of 10 Helix-PCDs


With different tube dimensions (see table below). Dimensions are optimized to test fractionated vacuum
cycles in steam sterilization processes. The can also be used in other sterilization processes.

All PCDs of the testset are also available separately:


Tube
Art-No. Product Code
Diameter [mm] Length [cm]
200-150 PM-HPCD-2-150 150
200-302 PM-HPCD-2-300 2 300
200-452 PM-HPCD-2-450 450
200-153 PM-HPCD-3-150 150
3
200-303 PM-HPCD-3-300 300
200-154 PM-HPCD-4-150 150
4
200-304 PM-HPCD-4-300 300
200-155 PM-HPCD-5-100 100
200-205 PM-HPCD-5-200 5 200
Art.-No.: 200-011, PM-HPCD-TS-10-FR 200-305 PM-HPCD-5-300 300

5.2.2 Testset consisting of 5 Helix-PCDs


With different tube dimensions (see table below). Dimensions are optimized to test small steam sterilizers.
However the PCDs can also be used in other sterilization processes/sterilizers.

All PCDs of the testset are also available separately:

Tube
Art-No. Product Code
Diameter [mm] Length [cm]
200-025 PM-HPCD-2-25 25
200-050 PM-HPCD-2-50 50
200-075 PM-HPCD-2-75 2 75
200-100 PM-HPCD-2-100 100
200-150 PM-HPCD-2-150 150

Art.-No.: 200-013, PM-HPCD-TS-5

710-002 EN V22 06/2013 Page 20 of 28


6. Documentation system

6.1 Hand labelling devices


gke offers three different versions:
N= numeric version: The first printing line contains three alphanumeric
characters to print the responsible person’s initials as well as nine
numeric characters to print the sterilizer and batch number.
(Art.-No. 240-850)
A= alphanumeric version: The first printing line contains 12 alphanumer-
ic characters to print words and/or numbers. (Art.-No. 240-840)
AL = alphanumeric version: see A-version, however less force is required,
to press the labeler, proving less printing pressure to the label with
the result that the ink roll might have to be exchanged more often.
(Art.-No. 240-830)
See data sheet “Documentation System” for further information.
The lines should contain the following information:
Person responsible
Sterilizer no.
Batch no.
Package content

EM 01 02 11 Sterilization process
gke-Steri-Record® Process indicator
2010-10-25 Production date Indicator colour change
   
2011-01-25 Expiry date gke-Steri-Record®

6.2 3-line single self-adhesive documentation labels


available with or without steam process indicators. Each roll contains 1.000 labels (no ink roll included).

6.2.1 without indicator

Art.-No.: 230-864

6.2.2 with indicator for steam sterilization processes

Art.-No.: 230-871 -872 -873 -874

710-002 EN V22 06/2013 Page 21 of 28


6.3 3-line double self-adhesive documentation labels
with advanced adhesion properties
The label may be adhered directly on the pack or on top of other process indicators. Before the pack is
opened in the operation room the label is taken off and pasted to the patient documentation. It is available
in 4 colours with steam process indicators and with a process indicator for ethylene oxide sterilization
processes (colour: purple), formaldehyde sterilization processes (colour: red) and hydrogen peroxide
(plasma) sterilization process (colour: green). Each pack contains 4 or 12 rolls with 750 labels each and an
ink roll.

6.3.1 without indicator

Art.-No.: 240-861 -862 -863 (12 rolls) -864


-853 (4 rolls)

6.3.2 with indicator for steam sterilization processes

Art.-No.: 240-871 -872 -873 (12 rolls) -874


-883 (4 rolls)

6.3.3 with indicator for the following sterilization processes

Art.-No.: 242-875 (12 rolls) Art.-No.: 243-873 (12 rolls) Art.-No.: 244-871 (12 rolls)
242-885 (2 rolls) 243-883 (2 rolls) 244-881 (2 rolls)
ethylene oxide formaldehyde Hydrogen peroxide

710-002 EN V22 06/2013 Page 22 of 28


6.4 Double self-adhesive 3-line eco-labels
with standard adhesive quality, with or without indicator, no conformity declaration and no test reports
available. Each roll contains 750 labels, without ink roll.

Art.-No.: 000-863 Art.-No.: 000-873 Art.-No.: 000-875


without indicator steam ethylene oxide

6.5 Combination of different labels together with 3-line labels

C-S-P-5-58x35-SV1
Art.-No.: 211-220 + -222

C-S-L-1-CL-40x60-SA
Art.-No.: 211-341

C-S-L-1-CS
Art.-No.: 211-362

710-002 EN V22 06/2013 Page 23 of 28


7. Cleaning Indicators and PCDs

7.1 Cleaning indicators for WDs


Refill packs with self-adhesive cleaning indicators for validation and monitoring of cleaning processes, on
cards with 16 double-sided indicator each. The indicators can be used as double-sided indicators in the gke
holder (see 7.1.2) or in the Hollow Flow-PCD (see 7.1.3). They can be adhered for documentation.

Art.-No. 810-10x Art.-No. 810-20x Art.-No. 810-30x Art.-No. 810-40x Art.-No. 810-90x
Level 1 Level 2 Level 3 Level 4 Multi-Level

Art.-No. Product code Colour Quantity


Introduction pack with
16 Level 1-4 cleaning
800-004 W-WA-L1-4-KIT
indicators each +
3 plastic holders
Introduction pack with
800-005 W-WA-MLC-KIT 32 Multi-Level indica-
tors + 3 plastic holders
810-101 160
810-102 W-WA-L1 yellow 480
810-103 960
810-201 160
810-202 W-WA-L2 green 480
810-203 960
810-301 160
810-302 W-WA-L3 blue 480
810-303 960
810-401 160
810-402 W-WA-L4 red 480
810-403 960
810-901 green/ 160
810-902 W-WA-MLC blue/ 480
810-903 red 960

710-002 EN V22 06/2013 Page 24 of 28


7.1.2 Hollow Flow PCD

Art.-No. Product Code Content/Description


Hollow Flow-PCD with 3 different
adapters of 2, 3 and 4 mm split width
800-111 W-HF-PCD
as well as 2 LL-adapters and
a 0.5 m silicone tube

It is recommended to order this PCD together with one of two


introcuction packs (800-004 or 800-005).

7.1.3 Holder for cleaning indicators

Art.-No. Product code Description


800-100 W-HO Stainless steel holder
Plastic holder,
800-102 W-PHO
colour: orange

Stainless steel Plastic

7.1.4 Cleaning indicators for bedpan washers


gke has designed a special cleaning indicator to monitor the cleaning efficacy in bedpan washers.

Art.-No. Product code Colour Quantity


810-000 64
810-001 160
W-BP-L0 orange
810-002 480
810-003 960

Art.-No. 810-00x
Level 0

710-002 EN V22 06/2013 Page 25 of 28


7.2 Cleaning Indicators for ultrasonic cleaning baths
Refill packs with self-adhesive cleaning indicators to test ultrasonic cleaning baths, on card with 4
indicators each. The indicators are placed horizontally or vertically in the liquid volume to check the
cleaning efficacy inside the bath.

Art.-No. Product code Colour Quantity


Introduction pack with
800-014 W-U-L1-4 Level 1-4
cleaning indicators
810-111 40
810-112 W-U-L1 yellow 120
810-113 240
810-211 40
810-212 W-U-L2 green 120
810-213 240
810-311 40
810-312 W-U-L3 blue 120
810-313 240
810-411 40
810-412 W-U-L4 red 120
810-413 240

710-002 EN V22 06/2013 Page 26 of 28


710-002 EN V22 06/2013 Page 27 of 28
gke GmbH
Auf der Lind 10
D-65529 Waldems
Germany
 +49 61 26 94 32 - 0
 +49 61 26 94 32 - 10
 info@gke.eu
 www.gke.eu

710-002 EN V22 06/2013 Page 28 of 28

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